| Class 2 Device Recall Terumo Advanced Perfusion System 1 | |
Date Initiated by Firm | July 26, 2012 |
Date Posted | August 09, 2012 |
Recall Status1 |
Terminated 3 on November 16, 2012 |
Recall Number | Z-2178-2012 |
Recall Event ID |
62444 |
510(K)Number | K022947 |
Product Classification |
Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
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Product | System 1 base 220/240V
The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment. |
Code Information |
catalog number: 801764 and serial numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027, 1100-1434, 1436, 1440, and 1441. |
Recalling Firm/ Manufacturer |
Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor MI 48103-9586
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For Additional Information Contact | Tracy Ballanca 734-741-6173 |
Manufacturer Reason for Recall | Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall# Z-0882/0883-2011 RES 57416) regarding malfunctions of the Occluder and Air Bubble Detection (ABD) Modules to a confined number of Terumo Advanced Perfusion System 1 users. The investigation of the malfunction found a faulty component on the modules' application board caused the failures. Terumo CVS re |
FDA Determined Cause 2 | Component design/selection |
Action | The firm, Terumo CVS, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 26, 2012 to its customers. The letter described the product, problem and actions to be taken. To customers were instructed to review this Medical Device Recall notice and addendum; assure that all users are aware of this notice and addendum; place the addendum in the front of Section 7: Modules (p 7.1) and confirm receipt of this communication by faxing the attached Customer Response Form to the fax number/email address indicated on form.
Terumo CVS is issuing a Safety Advisory to alert all Terumo System 1 users of the potential for failure and providing an addendum for the Operator Manual with instruction on how to respond to the failure.
If you have any question or concerns contact Terumo CVS Customer Service at 1-800-521-2818. Customer Service hours are Monday-Friday, 8AM - 6PM ET. |
Quantity in Commerce | 649 units |
Distribution | Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Japan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DTQ
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